Mechanistic Oral Absorption Modeling and Simulation – FDA Workshop, May 19, 2016

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Mechanistic Oral Absorption Modeling and Simulation – FDA Workshop, May 19, 2016

Contributor: Sherry Ward, AltTox

Source: Federal Register

FDA public workshop: Mechanistic Oral Absorption Modeling and Simulation for Formulation Development and Bioequivalence Evaluation

Date: May 19, 2016, from 8:30 a.m. to 4:30 p.m.; must register on or before April 19, 2016

Location: FDA Conference Center at the White Oak Campus, Maryland

Purpose of the workshop

  1. Share FDA’s current experiences on the application of mechanism-based absorption modeling and simulation in regulatory activities;
  2. Discuss the current and future utility of mechanism-based absorption modeling and simulation in development of bioequivalent oral drug products and regulatory reviews; and
  3. Obtain input from the public on when, where, and how mechanism-based absorption modeling and simulation should be applied in development of bioequivalent oral drug products and review of bioequivalence.

The scope of the workshop covers the current status of mechanism-based absorption modeling and simulation from academia, industry, and regulatory perspectives.

The majority of drug products on the market are administered orally. Predicting oral bioavailability is always of great interest for pharmaceutical scientists. It has been a long journey for scientists to develop mechanistic absorption models for oral bioavailability prediction to reduce drug development time and cost, and to inform regulatory decisions. From simpler models to more complex ones, mechanism-based absorption models have been advanced substantially and their applications have been increasingly found in scientific literature and regulatory reports.

The high value of leveraging mechanistic absorption models in the development and evaluation of bioequivalent drug products can be attributed to their incorporation of formulation factors. The focus of this public workshop is on the application of mechanistic absorption modeling and simulation for development of bioequivalent oral drug products and evaluation of bioequivalence, including discussing the areas in which mechanistic oral absorption models can contribute significantly, how the mechanistic absorption modeling and simulation should be conducted and evaluated, and inherent scientific challenges.

Public input will improve FDA’s current understanding of using mechanism-based absorption modeling and simulation in bioequivalence evaluation. The knowledge gained from, and consensus reached, through this workshop will be summarized and disseminated to the scientific community by publication(s).

Scope of Public Input Requested

FDA seeks input from the public on when, where, and how to utilize mechanism-based absorption modeling and simulation in the context of development of bioequivalent oral drug products and regulatory evaluation of bioequivalence. Specific topics to be addressed include:

  1. Identifying the areas in which mechanistic oral absorption models can contribute significantly during development of bioequivalent oral drug products and regulatory evaluation of bioequivalence;
  2. How mechanistic absorption modeling and simulation should be conducted and evaluated; and
  3. The scientific challenges in mechanistic oral absorption and simulation.